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Caprosyn SC-5626Recalls & reported problems

Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant

All models of Caprosyn (45)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521034778), received between Dec 5, 2022 and Dec 5, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1
  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 5, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, THE TAIL OF 5-0 SUTURE NEEDLE WAS BROKEN WHEN THE SKIN WAS SUTURED. AFTER DISCOVERY, THE REMNANT WAS FOUND IN TIME AND THE SUTURE WAS REPLACED IN TIME. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15920120 ↗

Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices

All SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices →

Sources and updates

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